The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Coordinator II to conduct the following: screening and enrolling participants in Oncology clinical trials, conduct informed consent per GCP guidelines, conduct patient visits per protocol schedule of events, follow clinical trial budget with each visit, document adverse events, medications, and procedures conducted at each visit, prepare lab kits for each patient visit, administer EKG's, quality of life and other procedures as trained, work with sponsors to answer visit queries, conduct study initiation visits, conduct point of care protocol training, assist Principal Investigator and nursing to develop protocol orders, as well as attend team meetings and educational training as required.

The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. The link to our website is https://www.uab.edu/onealcancercenter/.

Please attach a current resume with this application.

General Responsibilities

* To serve as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.

* To organize patient enrollment planning. To conduct quality assurance activities. To compile and analyze data.

* To develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

* To serve as a mentor to junior staff, including student assistants.

Key Duties & Responsibilities

* Serves as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities. Organizes patient enrollment planning. Conducts quality assurance activities. Compiles and analyzes data. Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.

* Coordinates patient care and/or patient follow-up functions of the clinical study including planning and developing related activities. Arranges access to study medications, including authorization for prescriptions. Employs strategies to maintain recruitment and retention rates.

* Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).

* Manages investigational products (IP). Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.

* In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives. Compiles, edits and proofs written reports for both internal and external administrative offices. Provides data for the creation of study budgets as needed.

* Completes Case Report Forms (CRF) according to protocol. Assists with development of standard operating procedures (SOPs) for data quality assurance.

* Performs vendor analysis and equipment configuration as needed. May perform a variety of medical procedures.

* Under the oversight of the Investigator, develops protocols, identified efficiencies and improves processes. Serves as a mentor to junior staff, including student assistants. Arranges multidisciplinary evaluations.

* Maintains compliance with federal, state and accrediting agencies (sponsors).

* Maintains any required documentation.

* Manages site supplies as needed.

* Serves as a mentor to junior staff, including student assistants.

* Performs other duties as assigned.

Annual Salary Range: $50,050.00 - $81,330.00

* Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

* Clinical Research experience.

* Prior experience coordinating research activities involved in conducting Oncology clinical trials.

* Prior experience with data management.

* Knowledge of regulatory/compliance affairs as it pertains to clinical research.